Key result
Understanding medical device regulation, including FDA premarket evaluation and postmarket surveillance, is essential for practicing physicians involved in patient care and device-related research.
Design
Review
Authors
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Emphasizes regulatory literacy for device-involved clinicians; leaves open optimal training integration strategies.
Provides an overview of medical device regulation by the FDA and the role of practicing physicians in device design, safety, and postmarket surveillance.
William H. Maisel (2004) conducted a review in Medical device regulation. Understanding medical device regulation, including FDA premarket evaluation and postmarket surveillance, is essential for practicing physicians involved in patient care and device-related research.
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